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| [ ...Back to search results ] | [ Print-friendly version ] |
| United Kingdom Asian Diabetes Study |
| Source of record | UK Trials |
| ISRCTN | ISRCTN38297969 |
| Date ISRCTN assigned | 14/09/2005 |
| Local reference number(s) | 2 |
| Public title | United Kingdom Asian Diabetes Study |
| Scientific title | |
| Acronym | UKADS |
| Disease/condition/study domain | Type 2 diabetes |
| Study hypothesis | Structured care for diabetes, tailored to the needs of the Asian community, will improve surrogate endpoints for diabetic complications (and by extrapolation morbidity and mortality) in South Asian patients with type 2 diabetes. This will require the extra resources of Asian link workers, additional practice nurse time and community Diabetes Specialist Nurse input, working to protocols with clearly defined targets. |
| Design/methodology | Randomised controlled trial |
| Research ethics review | Not provided at time of registration. |
| Countries of trial | United Kingdom |
| Participants - inclusion criteria | Patients of South Asian ethnic background with type 2 diabetes. |
| Participants - exclusion criteria | 1. Patients not of South Asian ethnic background 2. Diabetes other than type 2 diabetes |
| Patient information material | |
| Anticipated start date | 01/03/2004 |
| Anticipated end date | 01/03/2007 |
| Status of trial | Completed |
| Target number of participants | 1800 |
| Interventions | A complex intervention package comprising specialist diabetes nurse co-ordinators working with practice nurses to implement protocols for the treatment of blood pressure, blood lipid and blood glucose levels. The protocols use simple treatment algorithms and have strict targets. Practice nurse time and training are protected and enhanced, and practice nurses work with Asian link workers to facilitate cultural acceptability of treatment and compliance. DNA samples will be prepared in order to investigate the genetic determinants of high density lipoprotein (HDL) cholesterol levels and latent autoimmune diabetes of adults (LADA), the genetic susceptibility to microalbuminuria and candidate susceptibility genes for type 2 diabetes and components of the metabolic syndrome. Control: usual care |
| Primary outcome measure(s) | Acheivement of targets as set out in treatment algorithms: 1. Blood pressure (130/80 mmHg) 2. Lipid profile (total cholesterol less than 4.0 mmol/l, low density lioprotein [LDL] cholesterol less than 2.5 mmol/l, triglycerides less than 2.0 mmol/l) 3. Glycaemic control (HbA1c less than 7.0%) |
| Secondary outcome measure(s) | 1. Development and progression of microalbuminuria and proteinuria 2. Mortality from any cause 3. Micro- and macro-vascular complications |
| Publications | Results in http://www.ncbi.nlm.nih.gov/pubmed/15569141 |
| Sources of funding | 1. Pfizer Ltd (UK) 2. Sanofi-Aventis (UK) 3. Servier Laboratories Ltd (UK) 4. Merck, Sharp and Dohme - Schering Plough Limited (UK) 5. Takeda Ltd (UK) 6. Merck Pharmaceuticals (UK) 7. Eli Lilly and Company Limited (UK) 8. Novo Nordisk Ltd (UK) 9. Boehringer Ingelheim GmbH (Germany) 10. British Heart Foundation (UK) |
| Sponsor name | Heart of England NHS Foundation Trust (UK) |
| Sponsor details | Birmingham Heartlands Hospital Bordesley Green East Birmingham United Kingdom B9 5SS |
| Sponsor telephone | +44 (0)121 424 3632 |
| Sponsor email | elizabeth.adey@heartofengland.nhs.uk |
| Contact name | Prof Anthony Barnett |
| Contact details | Undergraduate Centre Birmingham Heartlands Hospital Bordesley Green East Birmingham United Kingdom B9 5SS |
| Contact telephone | +44 (0)121 424 3587 |
| Contact fax | +44 (0)121 424 0593 |
| Contact email | anthony.barnett@heartofengland.nhs.uk |
| More information | For more up-to-date information please go to the ISRCTN link below. |
| Link to record in ISRCTN Register | ISRCTN38297969 |
| Date last extracted from ISRCTN register | 17/04/2008 |
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